A Food And Drug Administration Advisory Panel

OTHER NEWS TO NOTE - WASHINGTON

December 12, 1992

A Food and Drug Administration advisory panel has recommended that the FDA approve the first female condom. If approved by the FDA, the condom could be on the market as early as the summer 1993, according to the manufacturer.

Although the panel voted unanimously late Thursday to approve the Reality condom, it set out two conditions for approval: certain changes to the labeling information and further studies to further test the condom's effectiveness.

The Reality condom, developed by Wisconsin Pharmacal of Jackson, Wis., is an adaptation of the one for men. It is a 7-inch tube with flexible rings at both ends. The inner ring fits behind the woman's pubic bone, and the outer ring remains outside her body.

According to studies done by the company, Reality provides protection comparable to other barrier contraceptives such as the cervical cap, sponge and diaphragm, although the female condom was not tested against any other product.

At Thursday's hearing, both panel members and FDA Commissioner David Kessler said they were frustrated by a lack of better information proving both safety and effectiveness of the condom.

The FDA does not have to accept the panel's recommendation. However, the FDA usually follows the advice of such committees. There is no timetable for its decision, but the agency is expected to act quickly.

The condom already is approved for use in Canada and is available in some European countries.